[Public Health] NPPA, Drug Price control, Sravan Implant, Cigarette packing rules update

Technology33 Comments

India Yearbook
  1. Prologue
  2. NPPA: National Pharmaceutical Pricing Authority
    1. Drug pricing controversy
    2. Scene 1: NPPA price controls begins (Dec 2013)
    3. Scene 2: NPPA tries to go beyond its mandate
    4. Scene 3: NPPA humiliated*
    5. Behind the curtains
  3. Sravan implant
  4. Cigar-Labelling

Prologue

Current affairs related to public health, during September Week1 to October Week3.

  • Part1: Mother, Children, Hunger, Nutrition related.
  • Part2: Policy / Mission: Mental health, Ayush
  • Part3: “Selling” related: NPPA, Sravan implant, Cigar labelling. You’re here.

NPPA: National Pharmaceutical Pricing Authority

Topic in NewsSept. 2014
Relevance(GSM2) Statutory, regulatory and various  quasi-judicial  bodies

Q.Write a short note on National Pharmaceutical Pricing Authority(NPPA). 100 words.

  • NPPA is an Attached office under Department of Chemical and petrochemical, under Ministry of chemicals, fertilisers and pharmaceuticals. (and not under health Department)
  • Motto: Affordable medicine for all.

Functions

  • Under Essential commodities Act (ECA), Government had issued Drug price control order.
  • NPPA enforce this Drug price control order.
  • It monitors drugs production, availability, import-export database
  • Tries to prevent shortage of drugs.
  • Advices Government on drug policy.
  • Doesn’t deal with drug licensing or clinical trials. Those functions are under Drugs control general of India (DGCI) under health ministry.

Drug pricing controversy

NPPA drug price control explained

Gist of NPPA Drug price control controversy

Relevance: (GSM3) issues relating to intellectual property rights.

Scene 1: NPPA price controls begins (Dec 2013)

  • Government passes drug price control order. (DPCO)
  • Earlier a Committee had prepared the National list of essential medicines (NLEM) with total 348 drugs. NPPA begins controlling their price.

Drug pricing formula

  • Take MRP of all companies having >1% market share.
  • Take average of those MRPs.
  • No company can sell drug at price above that ceiling.

But Mind it: This formula applies only to those 348 drugs.

Scene 2: NPPA tries to go beyond its mandate

  • 2014, May month: NPPA issued new price control order on ~108 non-scheduled medicines, dealing with heart, diabetes, TB and cancer.
Arguments from both sides:
NPPA saysPharma companies say
Yes, those drugs are not in the NLEM list, but under Drug price control order (DPCO-2013) paragraph 19,  I’ve the powers to control prices of drugs outside NLEM-list during shortage, emergency and extraordinary circumstances.Those 108 drugs are not in NLEM, and there is no shortage. Therefore, you’ve no authority to control their prices.
  • Matter goes to Delhi Highcourt. Taarikh pe Taarikh…Fast forward to:

Scene 3: NPPA humiliated*

*Just like Indian cricket team in every second or third match.

  • 2014, September: Government revokes that paragraph 19 from Drug price control order.
  • Therefore, NPPA automatically lost power to control prices of those 108 drugs which are not in the NLEM-list.  (National list of essential medicine).
Consequence of Government decision
DrugPrice BeforeAfter Sep’14
Glivec (Novartis)85001 lakh
Veenat (NATCO)850011,500
Plavix1471,615

But NPPA is not sitting idle.

  • NPPA began updating the NLEM list on Government advice. (in other words, they’ll try to add those 108 drugs within NLEM, and thus get automatic power to control their prices as well.)
  • Last time, NPPA updated the list 8 years ago, but it came into effect 4 years ago. So it remains to be seen how long it takes this time.
  • Obviously, pharma companies don’t like this. Hence more court cases ahead, topic to remain in news forever to harass UPSC aspirants and B.Pharma grads. in job and MBA interviews.

Behind the curtains

  • Scene1: USA has put India under “priority watch list” in the “Special 301 report” because of the “unfavorable” IPR regime. Pharma MNCs always criticize India for unfavorable patent and pricing rules.
  • Scene2: Government removed price control (to benefit those pharma MNCs) just before Modi visited USA in September 2014.
  • Scene3: USA began “out of turn review” of India under special 301 report in October 2014.

If you connect the dots: Modi revoked drug control to get India out of the watchlist in special 301 report. Consequences?

  • Drugs will get expensive
  • Pharma MNCs may increase ‘investment’ and thereby jobs in India.

Although it doesn’t mean Pharma MNCs only operate to rob and loot everyone on 24/7 basis. In 2014, September. Gilead (US co.) signed agreement with 7 Indian pharma companies, permitting them mfg. and sell Hepatitis C drug (Sofosbuvir/Sovaldi) at an affordable price in India.

Sravan implant

Topic in NewsSep.W3, 2014
Relevance(GSM3) Indigenization of technology

Q. Write a note on Sravan Implant. 100 words

Sravan cochlear implant- Cheaper than imported machines

Sravan cochlear implant

  • 10 lakh Indians suffering from hearing loss. 10,000 newborn with same problem.
  • Cochlear implant / bionic ear: It gives hearing perception to such patients.
  • Problem? Imported device costs nearly 8 lakh rupees.
  • Solution? DRDO, Armed forces medical college and other Indian labs have produced a cheap device named “Sravan Implant”.
  • It has two units (1) Cochlear implant (2) speech processor.
  • Costing ~1-1.5 lakh rupees = cheapest in the world but without compromising quality.
  • It is not for sale yet. They’ve filed clinical trial application to DGCI (Drug controller general of India).

Cigar-Labelling

Topic in NewsOctober W3, 2014
RelevanceEssay fodder  / Interview.
  • India had signed and ratified WHO Framework Convention on Tobacco Control
  • But so far has not complied with the minimum rules.
why India sucks on WHO parameters?
Other countriesIndia
Cigar packs need to display pictorial warning on both sides of the packOnly 1 side. Covering only 20% area
  • Recent report even says India sucks the most among SAARC nations in package-warning.
  • Consequences: social cost of tobacco use= Rs.~1.5 lakh crores in cancer and death (2011)
  • Solution: Finally Government woke up and amended the Tobacco products packaging rules. (in Oct 2014)

W.E.F. from 1st April 2015:

  • Every cigarette packet will carry the statutory warning on both sides, covering total 80% area.
  • with photo of throat cancer (60% space)
  • With message in English, Hindi or any Indian language. (25% space)
  • Benefit? Customer most likely to notice those gory images and give up smoking sooner or later.

Criticism

  1. Most rural men use bidis, they don’t contain such labels.
  2. Most urban youth too cheap to buy entire packet. They only buy 1-2 cigarates loose from the vendor. Hence unlikely to see the gory images
  3. Ban on smoking in public places, is not strictly enforced.

Mrunal recommends

  1. (free) NCERT, NIOS, TN-Books
  2. Environment by ShankarIAS
  3. Indian Polity M.Laxmikanth (Hindi | English)
  4. Art & Culture by Nitin Singhania (Hindi | English)
  5. Spectrum: Modern History (Hindi | English)
  6. Bipin Chandra: Post Independence
  7. Fast-track to Arithmetic Rajesh Verma
  8. MK Pandey’s Analytical Reasoning
  9. Disha’s Topicwise Paperset (Hindi | English)
  10. School Atlas
  11. Mains: Language papers
  1. (free) NCERT, NIOS, TN-Books 4 History,Geo,Sci
  2. Indian Polity M.Laxmikanth (Hindi | English)
  3. Spectrum: Modern History (Hindi | English)
  4. Maths: Quantam CAT Sarvesh Kumar
  5. Objective General English SP Bakshi
  6. Word Power made Easy -Norman Lowe
  7. Topic wise Solved Paperset by Disha


So far 33 Comments posted

  1. santro

    nicee

    Please relate the public health series with MDG Goals completion adn SDG post 2015 targe

    1. umeshwar singh

      please sir provide matter on modi visit bhutan and nepal

  2. publichealthfreak

    Scheduled drugs are not same as Essential medicines. Schedules appear in the Drug and Cosmetic Rules and lists different preparations. Eg- Schedule X contains narcotics. Each schedule has specific rules for dispensing drugs contained in them. Essential drugs are a small subset of drugs in all schedules and contains preparations from many different Schedules. NLEM is prepared by MoHFW.

    1. raju

      i have same que.

  3. AB

    Hi..Anyone wants to share Insight test series.??Please let me know.Because it cost bit high for me.So please let me know the mail id if anyone is interested to share..

  4. sanjay ranjan

    Thanks, very useful article.

  5. gaurav

    Respected sir , you wrote a nice article but i want to pin point 2-3 issues regarding nppa and i hv it will be taken as constructive critisim. – 1. Nlem made by core committee of industry experts set up by dept of pharmaceuticals NOT by nppa. 2. Nppa is saying @108 non- nlem that there exist huge interbrand diff. Which is indicative market failure therefore extraordinary situation but industry says inter brand diff would always be there in every single formulation which is manufactured by more than one formulator so no market failure. 3. Solisitor general – nppa had overreached its authority. 4 . Nppa will not be able to control prices of non nlem drugs prospectively from 22 sep 2014 but order regarding 108 will be there till sc decides on it.

    1. pappupager

      oh come on ,dont do this injustice .Mrunal Sir follow a specific ideology that is semi modi bhakti (dont call me congressi..i also voted for congress)

  6. gaurav

    @ gileed agreement – 1. – mnc afraid about compulsory license. 2 . Matter under cci scanner. 3 they think if we deal with desi companies we will have to share profit but still get monopoly rent and makes sure that lees no of campanes remain to make cheaper drugs by grant of CL. Mncs are there only for profit. At least i think so

  7. ankush

    nyone plzz tell mehow to prepare for nicl ao exam

    this is my oly hope fr a govt job

    1. Vaibhav

      Prepare for Normal IBPS Exam and Solve Papers, This would be enough for preparing for NICL AO Too.

  8. Swati

    Hi Sir. . .can u plz try to put up topic list for Current Affairs for june-august?? Ur list is quite comprehensive. . .will b helpful for checking missed topics. .

  9. srimay

    I completely agree with you that MNCs are there to cough of huge profit, but at the same time they ensure high quality & standard of medicines which sometime the indian mfg are not able to deliver. The recent FDA inspection of few of the well known indian companies like Ranbaxy, Sun, Wockhardt & putting heft fine & regulation are evidence of compromised practice of Indian Companies.

    However providing cheaper alternative in health care surely an inevitable matter but how so ever it should not be happen at the cost of free market competition. There are n no of brands are now available in the market for a particular formulation, & I think the customer should have a choice of his own.

    If the govt is thinking of affordable healthcare for all let them introduce universal health care policy or govt supply of medicines like the Tamil Nadu & Kerala model which is precisely a good alternative.

  10. the warlock

    Agree with @gaurav

    I request @shivram to please update the article

    We rely heavily on Mrunal.org and take prints of the articles, incorrect fodder material would be a disaster in exam.

  11. sandeep

    Good to see this article. I have worked on this project…….final list was prepared and submitted by me to NPPA authority

  12. ilan

    When will upsc release capf 2014 results ? You have any idea ?

  13. sachin

    mrunal sir , What are the major problems of Pharmaceutical industries in India?

  14. keshav shandilya

    sir, please write an article on LOK ADALAT and CONSUMER COURTS”s jurisdiction, powers,authorities,and proceedings. I .m not getting the sufficient material on it. pls help me.

  15. 2015

    Thank you, mrunal.

  16. RAHUL

    Dear sir,
    we all know deadly side effect of tobacco.if government is so serious about its effect on health then why don,t government put ban the production and sales of tobacco products?????

    1. NIKHIL

      it is because of its after effects…
      if govt. do that then there will be rise in illegal supply…..which will further increases the problem of the govt….

      1. RAHUL

        @ nikhil…thnx bro….but i think tax implemantation sud b on the basis of tabaco contant…higher d tobacco contnt higher the tax…not on the basis of length of cigrate….

  17. gaurav

    Can anyone suggest what to read for GS3 Science and Tech related part?????

  18. ias

    plz koi muje bataye ki kab tak hindu padna hai…I am writing mains this time..also I covered hindu till 22 oct 2014..Some r suggesting me to read till 15 nov..my focus is to revise everything I read rather than adding anything new..plz mrunal sir do reply

  19. RBZRD

    “Most urban youth too cheap to buy entire packet. They only buy 1-2 cigarettes loose from the vendor.” That’s exactly what I thought of when the new cigarette packets with the warning images came out at first. Hahaha!

  20. Ashish Jadhav

    thank you sir

  21. ash

    what is special 301 report ?

  22. M.Subashini

    how nppa is related to IPR policy wrt spl301 ? couldn get that point immediately

  23. Sharan

    @Rahul

    We have learned definition of “State” in polity, but there is another definition. State exists, where one department promotes and another suppresses. 😀 😀
    Immediate Banning of Tobacco is not possible:

    1. Tribal livelihood largely depends upon tobacco cultivation. It’s obligates Govt. to arrange livelihood alternative for tribal’s or LET THE TOBACCO FLOURISH. Otherwise “Ministry of Social Justice & Empowerment” will wage war against “Ministry of Health and Family Welfare”.

    2. Prolonged consumption of tobacco makes body dependent of tobacco, therefore immediate curbing supply will leave large population in distress and possibly will lead them a step further for DRUGS ( LSD for example).

    Therefore, phasing out tobacco in phased manner not in mission mode, otherwise situation may get worse.

    (i am favoring phased manner despite widespread cancer problems, this simply DO NOT think that I am tobacco/Cigarette addict, because i am NOT)

  24. Amar prasad

    Lots of Thanks mrunal sir

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